Prevention of COVID-19 with 2-dose mRNA vaccine among healthy Children 6 month to 4 years who had COVID-19 infection SARS-CoV-2, mRNA vaccine, Infant, Children, Immunogenicity, Reactogenicity
Conditions
Interventions
Had COVID-19 August 1,2021 to November 30,2021,Had COVID-19 February 1,2022 to December 31,2022
Prevention,Prevention
Children 6month to 4 years had COVID-19 during the Delta predominant ,Children 6month to 4years had COVID-19 during the Omicron predominant
Sponsors
Ratchadaphisek Sompoch Research Fund
No Study Secondary Sponsor
Eligibility
Sex/Gender
All
Age
6 Months to 4 Years
Inclusion criteria
Inclusion criteria: 1. Participants must age 6 months to <5 years old on the day of first dose vaccination. 2. Participants have never received vaccination against SARS-CoV-2 prior to study enrollment. 3. Participants must be in good health at the time of entry into the trial as determined by medical history, and the clinical judgment of the investigator. 4. Parent(s) or legally authorized representative(s) gave consent to participants in the trial. Group A: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. (Documented by Antigen detection test or PCR at SARS-CoV-2 during July1, 2021 to November30, 2021) Group B: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. (Documented by Antigen detection test or PCR at SARS-CoV-2 during February1, 2022 to December31, 2022 (the Omicron predominant Period) (Note*: exclude Time overlapping between the Delta and the Omicron predominant periods is during December, 2021 to January, 2022)
Exclusion criteria
Exclusion criteria: 1. Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs. 2. Receipt of immunoglobulins or blood products within 3 months of first vaccination. 3. Use of or anticipated need to use, within the next 6 months of any medications that may be associated with impaired immune responsiveness or with immunosuppression. 4. Presence of any acute illness required medical attention within 14 days of first vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immunogenicity 1 months after 2 dose regimen mRNA vaccine Geometric mean titer | — |
Secondary
| Measure | Time frame |
|---|---|
| safety 1 month after 2dose regimen percent | — |
Countries
Thailand
Contacts
Public ContactSupawan Papakhee
Faculty of Medicine,Chulalongkorn University
Outcome results
None listed